FDA.reportPublic FDA data

NEOSTIGMINE METHYLSULFATE

Product NDC
0548-9601
11-digit product format
005489601
Labeler code
0548
Product ID
0548-9601_32069cca-ad21-4afc-9c23-5ab376b0237a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
neostigmine methylsulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Amphastar Pharmaceuticals, Inc.
Application
ANDA209933
Marketing category
ANDA
Marketing start
2017-09-25
Substance
NEOSTIGMINE METHYLSULFATE
Active strength
.5 mg/mL
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NEOSTIGMINE METHYLSULFATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOSTIGMINE METHYLSULFATE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98IMH7M386
Rxcui311935, 311936

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f58f10d3-5fa9-4c2e-9a6e-77029e9ed80bProduct name120231002
6c2b16d0-96e9-444e-98c5-9883cd6eb72dProduct name220230316
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
ad279e69-d021-f6bd-1150-2b55f23832d5Product name920211014
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0548-9601-00NEOSTIGMINE METHYLSULFATE10 in 1 PACKAGEINJECTION106
0548-9601-00NEOSTIGMINE METHYLSULFATE1 in 1 CARTONINJECTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0548-9601-00ML - Milliliter0548-9601ccd407bc-a96f-424e-8313-2a2fea02931912017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0548-9601NEOSTIGMINE METHYLSULFATE INJECTION [AMPHASTAR PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 2 package rows20220827_e47a4a4c-0e7c-40b6-9950-5b3adadcac22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionPSNe47a4a4c-0e7c-40b6-9950-5b3adadcac226
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionPSNe47a4a4c-0e7c-40b6-9950-5b3adadcac226
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSCDe47a4a4c-0e7c-40b6-9950-5b3adadcac226
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSCDe47a4a4c-0e7c-40b6-9950-5b3adadcac226
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSYe47a4a4c-0e7c-40b6-9950-5b3adadcac226
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSYe47a4a4c-0e7c-40b6-9950-5b3adadcac226

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0548-9601-000054896010010 CARTON in 1 PACKAGE (0548-9601-00) / 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE10 carton2017-09-250000-00-00NoNoCurrent